4/15/2015 Warning Letters > KIND, LLC 3/17/15 U.S. Food and Drug Administration Protecting and Promoting Your Health KIND, LLC 3/17/15 Department of Health and Human Services Public Health Service Food and Drug Administration College Park, MD 20740 WARNING LETTER MAR 17, 2015 VIA OVERNIGHT DELIVERY Daniel Lubetsky, CEO Kind, LLC 55 West 21st Street New York, New York 10010-6809 Re: 437043 Dear Mr. Lubetsky, The Food and Drug Administration (FDA) reviewed the labels for your Kind Fruit & Nut Almond & Apricot, Kind Fruit & Nut Almond & Coconut, Kind Plus Peanut Butter Dark Chocolate + Protein, and Kind Plus Dark Chocolate Cherry Cashew + Antioxidants products in August, 2014. The labels for these products direct the consumer to your website at the Internet address www.kindsnacks.com. We examined your website in October 2014. Based on our review, we have concluded that these products are in violation of section 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343] and its implementing regulations found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find the Act and FDA regulations through http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm440942.htm 1/9 4/15/2015 Warning Letters > KIND, LLC 3/17/15 links on FDA’s home page at http://www.fda.gov (http://www.fda.gov/). The significant violations are as follows: 1. Your Kind Fruit & Nut Almond & Apricot, Kind Fruit & Nut Almond & Coconut, Kind Plus Peanut Butter Dark Chocolate + Protein, and Kind Plus Dark Chocolate Cherry Cashew + Antioxidants products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear nutrient content claims, but the products do not meet the requirements to make such claims. Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient on the food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act. Specifically: a. The labels of your Kind Fruit & Nut Almond & Apricot, Kind Fruit & Nut Almond & Coconut, Kind Plus Peanut Butter Dark Chocolate + Protein, and Kind Plus Dark Chocolate Cherry Cashew + Antioxidants products bear an implied nutrient content claim, because they bear statements suggesting that the product may be useful in maintaining healthy dietary practices, and those statements are made in connection with claims or statements about nutrients. Specifically, the labels of the aforementioned products bear the claim “Healthy and tasty, convenient and wholesome” in connection with statements such as: “good source of fiber,” “no trans fats,” “very low sodium” [Kind Fruit & Nut Almond & Apricot, Kind Fruit & Nut Almond & Coconut, and Kind Plus Dark Chocolate Cherry Cashew + Antioxidants], “low sodium” [Kind Plus Peanut Butter Dark Chocolate + Protein], “+ antioxidants” [Kind Plus Dark Chocolate Cherry Cashew + Antioxidants], “50% DV antioxidants vitamins A, C and E” [Kind Plus Dark Chocolate Cherry Cashew + Antioxidants], “+ protein” [Kind Plus Peanut Butter Dark Chocolate + Protein], and “7g protein” [Kind Plus Peanut Butter Dark Chocolate + Protein]. Additionally, your website at http://www.kindsnacks.com/about/ states, “There’s healthy. There’s http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm440942.htm 2/9 4/15/2015 Warning Letters > KIND, LLC 3/17/15 tasty. Then there’s healthy and tasty” and “all of our snacks are pretty much the nirvana of healthful tastiness.” In addition, your webpage for the Kind Peanut Butter Dark Chocolate + Protein product at www.kindsnacks.com/products/kind-store/buy-kind-bars/kind-plus/peanut- butter-darkchocolate-protein.html states “KIND Peanut Butter Dark Chocolate + Protein is a healthy and satisfying blend of peanuts and antioxidant-rich dark chocolate. Each bar contains 7 grams of protein, which promotes satiety and strengthens bones, muscles and skin.” However, none of your products listed above meet the requirements for use of the nutrient content claim “healthy” that are set forth in 21 CFR 101.65(d)(2). In accordance with 21 CFR 101.65(d)(2), you may use the term “healthy” as an implied nutrient content claim on the label or in the labeling of a food provided that the food, among other things, is “low saturated fat” as defined in 21 CFR 101.62(c)(2) [i.e., the food has a saturated fat content of 1 g or less per Reference Amount Customarily Consumed (RACC) and no more than 15 percent of the calories are from saturated fat]. According to the Nutrition Facts panels: The Kind Fruit & Nut Almond & Apricot product contains 3.5 g of saturated fat per 40 g of the food, The Kind Fruit & Nut Almond & Coconut product contains 5 g of saturated fat per 40 g of the food, The Kind Plus Peanut Butter Dark Chocolate + Protein product contains 3.5 g of saturated fat per 40 g of the food, and The Kind Fruit & Nut Dark Chocolate Cherry Cashew + Antioxidants contains 2.5 g of saturated fat per 40 g of the food. These amounts exceed 1 g of saturated fat per 40 g RACC. These amounts also exceed the maximum of 15% of calories from saturated fat in the “low saturated fat” definition. Accordingly, your products do not meet the requirements for use of the nutrient content claim “healthy” on a food label [21 CFR 101.65(d)(2)]. Your products are thus misbranded within the meaning of section 403(r)(1)(A) of the Act. b. Your Kind Peanut Butter Dark Chocolate + Protein and Kind Dark Chocolate Cherry Cashew + Antioxidants product labels bear the term “+” (plus) as part of the product name but the products do not comply with the requirements governing the use of this term. The term “+” as part of the names of your Kind Peanut Butter Dark Chocolate + Protein and Kind Dark Chocolate http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm440942.htm 3/9 4/15/2015 Warning Letters > KIND, LLC 3/17/15 Cherry Cashew + Antioxidants read in conjunction with “7 g Protein” and “50% DV Antioxidant, vitamins A, C and E,” respectively, meets the definition for a nutrient content claim because it characterizes the product’s level of vitamins and minerals, which are nutrients of the type required to be in nutrition labeling [21 CFR 101.13(b)]. The term “plus” is defined in 21 CFR 101.54(e). This term may be used on the label or in labeling of foods to describe the level of nutrients (such as vitamins and minerals) in the food, provided that: (1) the food contains at least 10 percent more of the Reference Daily Intake (RDI) or Daily Reference Value (DRV) for the nutrient per RACC consumed than an appropriate reference food, (2) where the claim is based on nutrients that are added to the food, that the fortification is in accordance with the policy on fortification of foods in 21 CFR 104.20, and (3) the claim bears the required information for relative claims as described in 21 CFR 101.13(j)(2) and 101.54(e)(1)(iii). However, neither product label states the identity of the reference food and the percentage (or fraction) that the nutrient is greater relative to the RDI or DRV declared in immediate proximity to the most prominent such claim. Accordingly, these products are misbranded within the meaning of section 403(r)(1)(A) of the Act because they bear the nutrient content claim "plus" but do not comply with the regulations governing the use of this claim. c. The product page for your KIND Peanut Butter Dark Chocolate + Protein product on your website at www.kindsnacks.com/products/kind-store/buy-kind-bars/kind-plus/peanut-butter- darkchocolate-protein.html includes the nutrient content claim “antioxidant- rich dark chocolate”; however, the product and its labeling do not meet the requirements for the use of such claim that are set forth in 21 CFR 101.54(g). The phrase “antioxidant-rich” characterizes the level of antioxidant nutrients in the product and, therefore, this claim is a nutrient content claim under 21 CFR 101.13(b). Nutrient content claims using the term “antioxidant” must comply with the requirements listed in 21 CFR 101.54(g). These requirements state, in part, that for a product to bear such a claim, an RDI must have been established for each of the nutrients that are the subject of the claim [21 CFR 101.54(g)(1)], and these nutrients must have recognized antioxidant activity [21 CFR 101.54(g)(2)]. The level of each nutrient that is the subject of the claim must also be sufficient to qualify for the claim under 21 CFR 101.54(b), (c), or (e) [21 CFR 101.54(g)(3)]. In addition, in order to qualify for a “rich” or “high antioxidant” claim the product must contain 20 percent or more of the RDI for nutrients that have recognized antioxidant activity, such as vitamin C, vitamin E, or beta carotene (when 10% or http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm440942.htm 4/9 4/15/2015 Warning Letters > KIND, LLC 3/17/15 more of the RDI for vitamin A is present as beta carotene) in accordance with 21 CFR 101.54(b). Based on the information in the Nutrition Facts label, this product contains 15% of the Daily Value (DV) of vitamin E and 0% of vitamin C and vitamin A.